eurofeedback training for insomnia disorder patients with chronic using hypnotics

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

1) Male and female the ages from 19 to 70
2) Those who have been taking drugs for the past 3 months or more for improving insomnia, and have not changed the type or dosage of sleeping pills regularly taken to improve insomnia within the last 2 weeks
3) Total Insomnia Severity Index (ISI) score of 15 or higher
4) Those who satisfy the DSM-5 insomnia diagnosis criteria
5) A person who voluntarily agrees to participate after explaining the purpose and characteristics of this clinical trial and signs the subject consent form

Exclusion Criteria

1) Those who have received Korean medicine treatment remedies(acupuncture, moxibustion, cupping and herbal medicine) and neurofeedback training for the purpose of improving insomnia within the last 4 weeks
2) Those who have started health supplements or other non-drug therapies (cognitive behavioral therapy, meditation, etc.) for the purpose of improving insomnia within the last 4 weeks, or are planning to start during the clinical trial period
3) People with unstable (uncontrollable) schizophrenia, mania, bipolar disorder, other mental illness diagnosed and currently being treated in the past 6 months, or an anxiety or depression sub-score on the Hospital Anxiety and Depression Scale (HADS) of 11 or higher
4) Those who have had substance abuse/dependence in the last 6 months
5) A person who has a history of suicide attempts or plans to commit suicide
6) Shift work that can clearly affect the life cycle
7) Those who have clear pain that interferes with sleep or a disease that may cause insomnia
8) Those with abnormal hormone levels in the thyroid function test (those with abnormal free T4 and TSH < 0.1 uIU/ml or TSH > 5.1 uIU/ml)
9) Those who are unsuitable to participate in clinical research according to clinical laboratory tests (if total bilirubin exceeds the upper limit of normal in the institution by more than twice, AST or ALT exceeds the upper limit of normal in the institution by more than 2.5 times, creatinine is normal in the institution If it exceeds 2.5 times the upper limit, if urine HCG is positive, if other significant values ??that may affect clinical research are obtained according to the judgment of the researcher
10) Serious chronic diseases, organic diseases of the brain (brain tumor, stroke, epilepsy) or chronic diseases (malignant tumors, tuberculosis, chronic liver disease, chronic renal disease, chronic heart disease, other rare metabolic diseases, hereditary diseases, hormonal disorders) etc.) diagnosed and receiving treatment
11) A person who has implanted an implant (eg, pacemaker, etc.) that is not suitable for neurofeedback training
12) Those who have participated or are currently participating in other clinical trials with interventions within the last 4 weeks
13) Pregnant women, lactating women, and those who plan to become pregnant
14) If it is judged difficult to comply with this protocol, such as treatment, visitation, or filling out a questionnaire
15) If the person in charge of other clinical research determines that it is not appropriate

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index, PSQI

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index, PSQI;Insomnia Severity Index, ISI;Subjective accompanying physical symptoms VAS;Korean- Symptom Check List 95, KSCL-95;The Core Seven-Emotions Inventory Short Form, CSEI-S;Pattern Identification Tool Insomnia, PIT-Insomnia;Quantative encephalogram, QEEG;actigraphy;sleep diary;EQ-5D, EQ-VAS, SF-36, HINT-8;Cost evaluation;polysomnography, PSG;Melatonin & Cortisol study;adverse Event, AE;laboratory tests, EKG;Hospital Anxiety and Depression Scale, HADS